Q3 2021 G1 Therapeutics Inc Earnings Call

Operator: Good day, and thank you for standing by. Welcome to the G1 Therapeutics 3rd Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Good day and thank you for standing by welcome to did you want they got beauty third quarter 2021 financial results conference call. At this time all participants are in a listen only mode. After the speaker presentation. There will be a question and answer session to ask a question.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press Star 1 on your telephone. If you require assistance during the conference, please press Star 0. I would now like to turn the conference over to your speaker today, Will Roberts. Thank you. Please go ahead.

During the session you will need to press star one on your telephone.

You require assistance during the Countrys. Please press star Zero I would now like the turning the conference over to your speaker to be will the topics. Thank you. Please go ahead.

William C. Roberts: Thank you, Gail, and welcome to the G1 conference call to discuss our third quarter 2021 financial results and business update. The press release on these financial results was issued this morning and can be found in the news section of our corporate website, G1 Therapeutics dot com. On this morning's call, the team will provide a business overview of the third quarter of 2021, including an update on our commercial progress in that period with Cocella, which was approved by the U.S. Food and Drug Administration on February 12, 2021, to decrease the incidence of chemotherapy-induced mildness depression in adult patients when administered prior to a platinum atopic site-containing regimen, or topatechin-containing regimen, for extensive-stage small cell lung cancer, or ESSCLC, and which became available on the channel in early March of 2021.

Thank you Gail.

Everyone and welcome to the <unk> conference call to discuss our first quarter 2021 financial results and business update.

Firstly on these financial results was issued this morning and can be found in the news section of our corporate website human therapeutics Dot com.

One is called the team will provide a business overview of the third quarter of 2021, including an update on our commercial progress in that period with the seller, which was approved by the U S food and drug administration on February 12, 2021 to decrease the incidence of chemotherapy induced smell of depression in adult patients when administered prior to flatten and it took us I think enbridge.

Women or Chuck if he can containing regimen for extensive stage small cell lung cancer or SCLC.

In which case came available in the channel in early March 2021.

William C. Roberts: At the end of the Q&A session, we'll follow these prepared remarks. Before we begin, I'd like to remind you that today's webcast contains forward-looking statements within the meaning of the Private Security Litigation Reform Act of 1995. Such statements represent management's judgment as of today and may involve risks and uncertainty that could cause actual results to differ materially from those expressed in or implied by these statements.

<unk> session will follow the prepared remarks.

Before we begin I'd like to remind you that today's webcast contains forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.

Such statements represent managements judgment as of today and May involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements.

William C. Roberts: For more information on such risk and uncertainties, please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website. Any forward-looking statements represent our views as of today, November 3rd, 2021. Joining us on the call today are Jack Bailey, our Chief Executive Officer; Jen Moses, our Chief Financial Officer; Andrew Perry, our Chief Commercial Officer; and Raj Malik, our Chief Medical Officer. And with that, I'll turn the call over to Jack. Jack

For more information on such risks and uncertainties. Please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website.

Forward looking statements represent our views as of today November three 2021.

Joining me on the call today are Jeff Bailey, our Chief Executive Officer, Jen Moses, our Chief Financial Officer, Andrew Hirsch, Our Chief Commercial Officer, and Raj Malik Chief Medical Officer, and with that I'll turn the call over to Jack.

John E. Bailey: Thanks Will. Good morning everyone, and thank you for joining us on the call today. We hope that you and your families are well. Today's headline from the third quarter is one of action and rapid execution to maximize the value of Cosella for patients, healthcare professionals, and investors alike. Cocella is a paradigm-changing drug. It is the first and only multi-lingual myeloprotection therapy to offer proactive protection against the dangerous impacts of myelosuppression when treating people living with small cell lung cancer, and we are experiencing a variety of important drivers.

Thanks, Good morning, everyone and thank you for joining us on the call today.

We hope that you and your families are well.

Today's headlines from the third quarter I, just wanted to action and rapid execution to maximize the value of course solid for patients health care professionals and investors.

Kusama is a paradigm changing drug.

Excuse me, it's the first and only multiline niche Milo protection therapy.

To offer proactive protection against the dangerous impacts of mindless depression, when treating people living with small cell lung cancer.

And we are experiencing a variety of important drivers.

John E. Bailey: Excuse me, a little bit of a head cold, or tailwinds such as an exceptional reimbursement environment with no pushback on reimbursement or file claims, along with a new permanent J-Code that went active only one month ago. High awareness and attention to treat, excellent user experience, and strong reorder. However, as most of you know from IQVIA and other data sources, the softness that we discussed on the last call continued throughout the quarter, driven by variable geographic performance and a lack of access to the largest account.

Excuse me a little bit of ahead Paul.

[laughter] or tailwind such as an exceptional reimbursement environment with no real pushback from reimbursement for final claims along with a new permanent J code that would have active only one month ago.

Hi awareness and attention to treat an excellent user experience and strong reorder.

However, as most of you know from our <unk> and other data sources.

Softness that we discussed on the last call continued throughout the quarter.

Driven by variable geographic performance and a lack of access to the largest accounts. We believe that this is eminently addressable.

John E. Bailey: We believe that this is imminently addressable, and as you will hear, we are well along in the process. Actions we've taken include hiring our new Chief Commercial Officer, Andrew Perry, who I will introduce shortly. And we are in the process of hiring with urgency a new supplemental G1 sales force to access these top accounts. As our co-promotion partner, Barrier Ingelheim continues to be aware of the need to strengthen the sales line in the near term. Excuse me.

You will hear we are well along in the process.

Actions. We've taken include hiring our new Chief commercial officer, and Barry <unk>.

Introduce shortly and we are in the process of hiring with urgency supplemental <unk> salesforce to access these top accounts.

As our co promotion partner <unk>.

<unk> continues to be aware of the need to strengthen the sales line in the near term.

John E. Bailey: So far, we have had good continuity in strategy. We are also taking bold and immediate action to rectify this near-term performance gap. Turning to the clinical side of the business, we also remain focused on the long game via our tumor agnostic clinical programs to ensure that we continuously develop new data with tricyclic in a variety of tumors, chemotherapeutic backbones, and in combination with other therapeutic agents to maximize the applicability of the drug to future treatment paradigms. For example, as you will hear from Raj, we expect to initiate two new studies later this quarter designed to do just that, one of which will assess tricyclic in combination with an ADC.

Excuse me so far we have good continuity in strategy.

We're also taking hold an immediate action to rectify this near term performance challenges.

Turning to the clinical side of the business. We also remain focused on the long game via our tumor agnostic clinical programs to ensure that we continuously develop new data with trying to cycle and a variety of tumors chemotherapy chemotherapy backbones.

And in combination with other therapeutic agents to maximize the applicability of the drug to future treatment paradigms.

For example, as you will hear from Raj, we expect to initiate two new studies later this quarter designed to do just that one of which will assess <unk> in combination with an agency.

John E. Bailey: We have a lot to update you on this morning, so I will first introduce Andrew Perry and ask him to cover our commercial efforts for the third quarter of 2021 with a focus on our tailwinds and how we are addressing our headwinds, including a review of where we are in hiring our new sales. Raj will then provide an update on some of our medical and clinical momentum during the third quarter. Finally, Jen will provide the financial results for the quarter, including that our cash runway now takes us into 2024. Then I'll be back for some clues and comments.

Now we have a lot to update you on this morning, I will first introduce Andrew Perry and ask Jim to cover our commercial efforts for the third quarter of 2021 with a focus on <unk> and how we are addressing more headwinds, including a review of.

Where we are in hiring a new sales force.

Raj will then provide an update on some of our medical and clinical momentum during the third quarter.

Finally, John will provide the financial results for the quarter, including that our cash runway now takes us into 2024.

Then I'll be back for some closing comments.

John E. Bailey: With that, I am very excited to introduce our new Chief Commercial Officer, Andrew Perry. Andrew has 25 years of strategic product leadership experience with specific expertise in launching new, innovative products in the U.S. market across a variety of therapeutic areas, including oncology, growing brands throughout the product license, and managing Co-Promotion Relationships. He's already fully integrated into the team, and I'm excited for all of you to get to know him. Thank you, Jack.

With that I am very excited to introduce our new Chief Commercial officer, Eric Andrew has 25 years of strategic product leadership experience with specific expertise in launching new innovative products in the U S market across a variety of therapeutic areas, including oncology.

Our growing brands throughout the product lifecycle and managing co promotion relationships.

It's already fully integrated into the team and I'm excited for all of you to get to know Andrew.

Andrew Perry: I'm glad to be with you today to talk a bit about a number of topics, including our tailwinds and headwinds, the softness many of you have already noted in data sources like IQVIA, and the aggressive steps we're taking to correct it and alter the sales trajectory, including an update on our progress with the new Supplemental G1 Salesforce, which I'll cover in depth. We booked $3.6 million in net sales of Fros And this was driven by successes in new accounts, but also accounts where Cosella has been embraced at multiple sites across their organization. So we're seeing evidence of not only increased breadth but also depth.

Thank you Jack I'm glad to be with you today to talk about a number of topics, including our tailwind on headwinds softness. Many of you already noted and data sources like <unk> and <unk>.

Whereas the steps, we're taking to correct on all.

The sales trajectory, including an update on our progress with the new supplemental G. One salesforce, which all covenant that.

We booked $3 6 million and net sales of wholesaler support ending September 30th representing a 60% growth in vial demand for them higher markup.

And this was driven by successes in new accounts, but also accounts for Capella has been embraced at multiple sites across their organization. So we're seeing evidence of not only increased breadth while also debt.

Andrew Perry: However, as we mentioned last quarter, we did see gaps in uptake in many of the top 100 largest organizations, which collectively treat over half of patients with extensive stage small cell lung cancer. Our G1 supplementary sales team will focus on driving adoption in these top 100 organizations. In my first 10 weeks, I've been focused on improving commercial execution. For example, we just recently had our first in-person national sales training meeting with BI. This was the first opportunity for the sales team to practice in-person and receive training on new resources and the pull-through of the new permanent JCOs.

However, as we mentioned last quarter, we let's see ops and uptake and many of the top 100 largest organizations, which collectively treat over half of patients with extensive stage small cell lung cancer.

RG one supplementary sales team will focus on driving adoption and these top 100 organizations.

And my first 10 weeks have been focused on improving commercial execution.

Example, we just recently had our first IND Parison national sales training and West <unk>.

This was our first opportunity for the sales team to practice and Parison and receive training on new resources until the new permanent J code.

Andrew Perry: Now, as Jack mentioned, we've got meaningful tailwinds that are in our favor, including an excellent reimbursement environment with no pushback on reimbursement of filed claims, a permanent J-code, strong awareness and intention to use, and excellent provider and patient experience, all of which I will cover separately. Physicians need to understand the clinical value of the product and what it will offer their practice when they use it for their patients with extensive stage small cell lung cancer.

I will start mentioned with get meaningful tail winds that are in our favor, including an excellent reimbursement environment with no pushback on reimbursement of filed claims.

Pamela J code strong awareness and intention to use and excellent provider and patient experience all of which I'll cover separately.

Our physicians need to understand the clinical volume product and portable offered their practice when they use it for their patients with extensive stage small cell lung cancer and thus process relies on sales representative access to key prescribers, which as Youll hear it is a core requirement of our new sales team.

Andrew Perry: And this process relies on sales representative access to key prescribers, which as you'll hear is a core requirement of our new sales team. And we don't have some of the traditional barriers like payer challenges that usually plague new products.

And we don't have some of the traditional body or as like payer challenges, usually pegged plague new products.

Andrew Perry: However, despite the lack of these barriers, we need focused execution to move our largest prescribers from general awareness to product adoption. Now, many clinics have limited ability to directly engage customers during Q2 and Q3 because they close down to both in-person rep visits and to any external engagement outside of the office, even in some cases to digital engagement. And while COVID doesn't help, great sales execution always benefits from sales representative access to key customers and high quality, trusted relationships.

However, despite the launch of these buyers we need focus execution to move our largest prescribers from general awareness to product adoption.

<unk> had limited ability to directly engage customers during Q2 in Q3, because they close to eligible then pass on.

Onto any external engagement outside of the office, even in some cases actually to digital engagement.

And while Covid doesn't help great sales execution all of these benefits from sales representative access to key customers and high quality trusted relationships and so we are moving rapidly to build G. One.

Andrew Perry: And so we are moving rapidly to build that at G1. So let's discuss the important tailwinders that I described a moment ago, starting with reimbursement. And the reimbursement landscape continues to go remarkably well. Through August, approximately 55% of patients have been Medicare Part B.

So let's discuss the important tailwind as I described a moment ago, starting with reimbursement.

On the reimbursement landscape continues to go remarkably well.

Through August approximately 55% has been Medicare part D.

Andrew Perry: Around 40% is commercial, and the remaining is medical. Payer coverage remains very strong, with payer policies in place or pending that provide coverage for approximately 80% of unlabeled patient lives. Four of the top five US payers have made positive formal coverage decisions since product availability. We have not seen any pushback in terms of reimbursement of filed claims.

Around 40% is commercial and the remaining is Medicaid payer covenants remains very strong with payer policies in place or pending that provides coverage for approximately 80% of on label patient lives.

One of the top five U S payers have made positive formal coverage decisions.

Availability, we have not seen any pushback in terms of reimbursement to file claims.

Andrew Perry: And you likely saw that our permanent J codes became effective on October 1st, just about a month ago. And this code provides important reimbursement reassurance, particularly for those community clinic practices that wait for a permanent J code before adopting a new product. It's a product-specific reimbursement code assigned to outpatient and physician-administered buy-and-bill products like Cocella to enable a more efficient and more predictable billing process. And this is important because some of the top 100 organizations have referenced the need for a permanent J-code before they can consider Cocella. And we have communicated this new permanent code to all of our customers. In the third quarter, over 75% of our demand came from community hospitals or clinics.

Are you likely saw that our permanent J code is effective on October 1st just about a month ago and this provides important reimbursement reassuring us, particularly for those community clinic practices. The wait for a permanent J code for developing a new product.

It's a product specific reimbursement code assigned to outpatient and physician administered by an bell products like full setup to enable a more efficient and a more predictable billing process and this is important because some of the top 100 organizations I've referenced the need for a permanent J code before they can consider casella.

And we have communicated that this new permanent code to all of our customers.

In the third quarter over 75% of our demand came from community hospitals or clinics and asphalt.

Andrew Perry: And as of the end of the quarter, we'd received orders from over 100 unique organizations, up from 68 at the end of June. 35 of those are from our top 100 priority organizations, up from 28 of the top 100 that ordered as of the end of June. And we've made good progress since the end of the quarter, with more of the top 100 priority organizations ordering for the first time in October.

At the end of the quarter, we'd received the orders from over 100 unique organizations up from 68 at the end of June.

45 of those are from our top 100 priority organizations up from 28 of the top 100.

As of the end of June.

<unk> made good progress since the end of the quarter with more of the top 100 part of the organizations are going for the first time in October.

Andrew Perry: Based on our experience with those 35 priority organizations using Cosella as of the end of the quarter, when things are done correctly, with the right account access and the right set-up of order sets, depth is driven across accounts affiliated with that tier of organizations. And we know of several examples, including one mid-sized system in the Mid-Atlantic area, where our teams have been able to create access to key stakeholders across the organization, engage with them to place Cocella into their processes, help them identify appropriate patients, and then see very rapid growth.

Based on our experience with those 35 priority organizations using Casella I was hoping you ended the quarter when things are done correctly with the right account access and the right setup of art that is driving across accounts affiliated with top tier organizations.

Several examples including one mid sized system and the mid Atlantic area.

Our teams have been able to create access to key stakeholders across the organization engaged with them to place co sell it into their process help them identify appropriate patients and then seeing very rapid growth.

Andrew Perry: Awareness has remained high since launch, currently at 55% for unaided awareness and 75% for aided awareness. Intention to use the product is also high, with approximately 70% of surveyed oncologists saying that they intend to use Cocella in their institutions within six months, with another 19% intending to use it in the next seven to 12 months. Now we believe this is the result of more than two dozen publications focused on Costella and a solid digital campaign.

Awareness has remained high since launch currently at 55% of our unaided awareness and 75% for aided awareness.

Intention to use the product that is also high with approximately 70% of surveyed oncologists, saying that they intend to use <unk> in their institutions within six months with another 19% intending to you that in the next seven to 12 months.

Now we believe this is a result of more than two dozen publications focused on cross sell on a solid digital campaign.

Andrew Perry: Moving a doctor from intention to use to actual usage requires sales representative access and engagement with multiple customer stakeholders, including the pharmacist, the nursing team, and, of course, the prescriber, to get the product on formulary and into the right order set so that it's available for use with appropriate patients. And even once that has been done, identifying that first patient who could benefit from Cosella and having that conversation with a customer when they're considering using the product for the first time is something that benefits from personal engagement.

But moving a doctor from intention to use to actual usage require a sales representative access and engagement with multiple customer stakeholders, including the pharmacy and nursing team and of course, the prescriber to get the product on formulary and then to the right artifact. So it's available for use with the appropriate patients.

Even once that has been done identifying that first patient who could benefit from Coca Cola and having that conversation with the customer when they're considering using the product first time is something that benefits from personal engagement.

Andrew Perry: And briefly on that topic, engagement has been mostly virtual today. As of the end of September, the BI team achieved around 65% reach by all methods, whether personal, virtual, or digital, with our 2,500 target HCPs. And as I said, reach on its own is not really a sufficient indicator of engagement moving forward.

And briefly on that topic engagement has been mostly vertical today.

At the end of September the <unk> team has achieved around 65% reached by all methods with our personal virtual our digital with our 2500 target HCP.

And I've said reached on its own is not really a sufficient indicator of engagement moving forward and the new <unk> one sales team will prioritize engagement through high quality and ideally and parison customer discussions.

Andrew Perry: And the new G1 sales team will prioritise engagement through high quality and ideally in-person customer discussion. Regarding experience with Procella, we continue to hear overwhelming positivity from doctors who have begun to use it with their patients. They tell us that Cocella is as highly effective at proactive multilineage myeloprotection in real-world use as it was in clinical trials. It sits smoothly in the clinic workflow, with no additional trips to the office or significant time and resources required.

Regarding <unk>, we continue to hear overwhelming positivity from doctors, who have begun to use it with their patients.

<unk> Castella as is highly effective at proactive multi lineage Milo protection in real world use as it more than clinical trials.

As such smoothly in the clinic workflow no additional trips to the office or significant time and share required and in general once a doctor tries cassella Trc becomes an advocate and we see this manifest as a high reorder rate of at least 75%.

Andrew Perry: And in general, once a doctor tries Cocella, he or she becomes an advocate, and we see this manifest as a high reorder rate of at least 75%. So some accounts are achieving 80% total share, and that can happen in as little as 30 years.

With Soma kind of achieving 80% total share and that can hop in as little as 30 days.

Andrew Perry: Finally, from a patient perspective... Our advocacy team is actively engaged with patient advocacy groups, and we've begun to get remarkable feedback from cancer survivors who have been prescribed Glocella. One recent example came from a woman who went through chemotherapy for small cell lung cancer twice, the second time after the availability of Cozella. She commented that she never felt worse than she did while on chemo the first time. It was so awful that she said she would never get chemo again.

Finally from a patient perspective.

Our advocacy team is actively engaged with patient advocacy groups and we've begun to get remarkable feedback from cancer survivors, who have been prescribed <unk>.

One recent example came from a woman who went through chemotherapy for small cell lung cancer twice.

The second time after the availability of <unk>.

She commented that she never felt worse than she did well on chemo. The first time. It was so awful, but she said she would never get chemo again.

Andrew Perry: And when circumstances did require chemo again, fortunately, her doctor was ready to add Cocella. And this time, in her words... I feel like I don't even have cancer, and I don't look like I'm sick. I can do anything.

And when circumstances required chemo again, Fortunately her ballpark was ranking to add wholesale and less time and hard work.

Feel like I don't even have cancer.

Look like I.

I can do that.

Andrew Perry: Now, for us at G1, we are highly motivated by patient experiences such as this, but we are also convinced, more than ever, of the potential of Crocella. So there's strong support for Cosella in accounts where we have rep access and physician and patient experience. But thus far, we have lacked the required demand creation firepower in many of the largest accounts.

For us at <unk>, one we are highly motivated by patient experiences such as that but we are also convinced more than ever on the potential of cross sell.

So the strong support for cross sell and accounts, where we have ramp access and physician and patient experience.

Thus far we have blocked the required demand creation firepower and many of the largest accounts. So I'll now cover our progress with the new G. One co sell a focused sales force.

Andrew Perry: So I'll now cover our progress with the new G1 Cosella-focused Salesforce. We believe that a novel and innovative launch product like Cosella will benefit from a sales team 100% dedicated to accessing and driving debt in those 100 organizations that provide care for more than half of the patients who could benefit from Cosella. We are hiring professionals with extensive tenure and experience in oncology sales and with a demonstrated ability to gain access to and be successful in the accounts we're focused on.

We believe our novel and innovative launch product like cross sell benefit from our sales team, 100% dedicated to accessing and driving that in those 100 organizations, which provide care for more than half of patients who could benefit from <unk>.

We are hiring professionals with extensive tenure and experience in oncology sales and whats demonstrated the ability to gain access to and be successful in the accounts we're focused on.

Andrew Perry: So to provide a sense of interest in these positions, we've received hundreds of applicants for the field positions and have identified several highly skilled priority candidates with the desired track record in each region. These candidates want to join G1 at this time, primarily because of innovation and opportunity.

So to provide a sense of interest in these positions. We've received hundreds of applicants for the fields possessions and have identified several highly skilled priority candidates with the desire of track record in each region.

And these kind of its wants to join one at this time, primarily because of innovation and opportunity they've done their research. They know castella as a novel breakthrough therapy and priority review drug. They know it has a novel mechanism of action juul commencing endorsement from end CCN strong reimbursement coverage.

Andrew Perry: They've done their research, and they know that Costella is a novel breakthrough therapy and priority review drug. They know it has a novel mechanism of action, dual committee endorsement from NCCN, strong reimbursement coverage, and no competition. They know all of that, and they want to share in driving the growth and success of Costella. So, as of today, we have already hired the Vice President of Sales, we have an offer accepted for a Regional Sales Director, and we also have offers out or accepted for four sales representatives, one of whom started earlier this week.

Competition.

All of that and they want to share and driving the growth and success of cross sell.

So as of today, we have already hired the vice President of sales we have an offer accepted for a regional sales director. We also have offers are accepted for four sales representatives one of them started earlier this week.

Andrew Perry: Just in these six individuals, we have nearly 100 years of collective selling experience in oncology. Overall, we expect to have a majority hired by year-end and in the field quickly. And to ensure that we can have them activated quickly, we are challenging the traditional launch model. Companies typically hire a sales team, train them up as a group, and launch them into the field together, but that's a protracted process that can take significant time.

Justin These six individuals we have nearly 100 years of collecting collective selling expedience and oncology.

We're all we expect to have a majority higher by year end and in the field quickly and then and to ensure that we can have them activated quickly we are challenging the traditional launch mall.

Companies typically higher sales team trained them up as a group launched them into the field together.

That's a protracted process that can take significant time, so our model is different and that we're hiring training and deploying these highly effective individuals into the field as they arrive, which should save time and allowed us to start seeing the impact of this new sales team more quickly.

Andrew Perry: So our model is different in that we're hiring, training, and deploying these highly effective individuals into the field as they arrive, which should save time and allow us to start seeing the impact of this new sales team more quickly. CoCell is a paradigm changing product that provides a unique benefit to patients with extensive stage small cell lung cancer undergoing chemotherapy. We know what caused the recent softness in cells, and as you've heard, we are directly and rapidly addressing it.

<unk>.

Because that was a paradigm changing product that provides a unique benefit to patients with extensive stage small cell lung cancer are undergoing chemotherapy.

What caused the recent softness in sales and as you've heard we are directly on rapidly addressing it.

Andrew Perry: I'm confident that these efforts will convincingly change the trajectory of uptake and enable Cocella to impact the lives of many more patients with small cell lung cancer. So with that, I'll now turn the call over to Raj for an update on our medical and clinical efforts during the third quarter.

I'm confident that these efforts will convincingly changed the trajectory of uptake and enabled to sell it to impact the lives of many more patients with small cell lung cancer. So with that I'll now turn the call over to Raj <unk> for an update on our medical and clinical efforts during the third quarter Raj.

Rajesh K. Malik: Thanks, Andrew, and good morning, everyone. I'm going to cover two topics. First, I will provide a brief update on two of our medical affairs efforts that directly support the commercial efforts, including ensuring that our new supplementary sales team is fully trained and ready for the future. I'll then provide an update on our clinical programs, including an update on a couple of new upcoming clinical trials that we have added to our pipeline. As Andrew mentioned, our data suggests that 70% of treating physicians intend to use Cocella within the next six months. But what about the other 30%?

Thanks, Andrew and good morning, everyone I'm going to cover two topics first I will provide a brief update on two of our medical affairs efforts that directly support the commercial efforts, including ensuring that our new supplementary sales team is fully trained and ready for the field.

I'll, then provide an update on our clinical programs, including an update on a couple of new upcoming clinical trials that we have added to our pipeline.

As Andrew mentioned, our data suggests that 70% of treating physicians intend to use the setup within the next six months, so what about the other 30%.

Rajesh K. Malik: In many cases, these physicians underestimate both the clinical and economic impact of multilineage chemotherapy-induced myelosuppression and the toxicity of standard small-cell lung cancer chemotherapy. As such, our medical team has developed a provider model, which we internally call Project Mirror, to help practices understand their own data on the clinical impact of multilineage model suppression in their clinic and the medical and economic value of appropriate use of Cosella. Through this program, G1 is engaging with key accounts to conduct real-world evidence analyses to hold up the mirror, if you will, and quantify the costs and burdens associated with multilineage model suppression. And to be clear, it's not just neutropenia we are talking about, but also anemia and thrombocytopenia, the amount of growth factor use, blood transfusions, dose delays, etc.

In many cases these physicians underestimate both the clinical and economic impact of multi lineage chemotherapy induced mile suppression and the toxicity of standard small cell lung cancer chemotherapy.

As such our medical team has developed a provider model, which we internally call project mirror to a health practices understand their own data on the clinical impact of multi lineage models are pressured in the clinic and the medical and economic value of appropriate use of cassava.

Through this program <unk> is engaging with key accounts to conduct real world evidence analyses to hold up the mirror, if you will and.

Quantify the costs and burdens associated with multi lineage model suppression.

And to be clear, it's not just neutropenia, we are talking about but also anemia and thrombocytopenia.

Well talk to use blood transfusions dose delays et cetera.

Rajesh K. Malik: Further, the medical affairs team will play an integral role in the training of the new G1 sales staff to ensure our G1 Oncology sales professionals are ready to make an immediate impact. The training of our sales colleagues will be conducted with the two-fold purpose of increasing their medical and scientific product knowledge and enabling compliant collaboration. And as always, our MSLs are actively available for HCP clinical discussion. Now, let's shift now to a clinical program. Overall, our approach to designing our clinical program is to monitor the evolution of future standards of care and develop trial-and-error cycles with these in mind. We must always anticipate the future landscape and conduct trials that will generate important data to maximize future usage in those settings.

Further the medical affairs team will play an integral role in the training of the new <unk> sales team to ensure our <unk> oncology sales professionals are ready to make an immediate impact the.

The training of our sales colleagues will be conducted with a twofold purpose of increasing their medical and scientific product knowledge.

And enabling compliant collaborations.

And as always our Msos are actively available for HCP clinical discussions.

Let's shift now to our clinical program update.

Overall, our approach to designing our clinical program is to monitor the evolution of future standards of care and develop trauma sites live with these in mind.

We must always anticipate the future landscape and conduct trials that will generate important data to maximize future usage in those settings.

Rajesh K. Malik: As the company evolves, this will include trials with a variety of additional chemotherapy backgrounds but also potential combinations with agents with a variety of novel anti-tumor mechanisms, like ADCs and anti-TIDGETs, TMP3s, and LAG3s. In that regard, as you saw in this morning's press release, we will initiate two new G1-sponsored trials later this quarter. The first study that we expect to initiate is a Phase II single-arm trial study of tralicyclib in combination with sasituzumab Govatikan and ADC in patients with locally advanced or metastatic triple negative breast cancer. This is an area where trialocyclib in our Phase II trial and this ADC have both shown survival benefits and could act synergistically to improve patient outcomes along with reduced myelosuppressive side effects common with some ADCs.

As the company evolves. This will include trials with a variety of additional chemotherapy backbone, but also potential combinations with agents with a variety of novel anti tumor mechanisms like adcs and anti tickets temporaries and light sweets.

In that regard you saw in this morning's press release, we will initiate two new <unk> sponsored trials later this quarter.

The first study that we expect to initiate is a phase II single arm trial study a trial of <unk> in combination with <unk> and <unk> ADC in patients with locally advanced or metastatic triple negative breast cancer.

This is an area, where China side live in our phase II trial, and this ADC have both shown survival benefits and could act synergistically to improve patient outcomes, along with reduced Milo suppressive side effects common with some adcs.

Rajesh K. Malik: We will provide more detail on the trial design once it is underway, but at this point, we expect initial model protection data and tumor response data in the second half of next year. The second is a Phase II single-arm study, which we discussed on the last call, to further support the anti-tumor mechanism of action of Tralis-Hype. We also expect to initiate this Phase II trial soon, in addition to providing further insights into the mechanism of action. These data should also provide support for novel combination approaches, aging with anti-TIGIT or LAG-3 antibodies, and investigating additional tumors.

We will provide more detail on the trial design once it is underway, but at this point, we expect initial model of protection data and tumor response data in the second half of next year.

The second is a phase two single arm study, which we discussed on the last call to further support the antitumor mechanism of action of <unk>.

We also expect to initiate this phase II trial soon.

In addition to providing further insights into the mechanism of action. These data should also provide provide support for novel combination approaches.

<unk> with anti <unk> antibodies and investigating additional tumor types.

Rajesh K. Malik: More information on the trial design will be provided once it is initiated, and we expect data from this trial in the second half of next year. I mentioned earlier that we must always anticipate the future landscape and conduct trials to maximize the future applicability of trial-aside. This is relevant to how we evaluate our ongoing study. The treatment landscape is changing rapidly in second and third-line non-small cell lung cancer away from docetaxel, the chemotherapy being used in our Phase II trial, thereby decreasing the market opportunity for this combination.

More information on the trial design will be provided once initiated and we expect data from this trial in the second half of next year.

I mentioned earlier that we must always anticipate the future landscape and conduct trials to maximize the future applicability of trailer side.

This is relevant to how we evaluate ongoing studies the treatment landscape is changing rapidly in second and third line non small cell lung cancer away from Docetaxel, a chemotherapy being used in our phase II trial.

Thereby decreasing the market opportunity for this combination.

Rajesh K. Malik: With that in mind, we've made the strategic decision to discontinue the second third-line non-small cell lung cancer phase 2 trial and reallocate those funds to support the two new phase 2 trials I just described. First-line non-small cell lung cancer, on the other hand, continues to be a significant unmet market opportunity, where chemo-checkpoint combinations are standard of care... Based on its mechanism of action, we believe there could be an improvement in outcomes by adding trial-as-filed liposomal therapy to this combination.

With that in mind, we've made the strategic decision to discontinue the second and third line non small cell lung cancer phase two trial and reallocate those funds to support the two new phase II trials I just described.

First line non small cell lung cancer on the other hand continues to be a significant unmet market opportunity, but chemo checkpoint combinations are standard of care.

Based on its mechanism of action, we believe that could be an improvement in outcomes by adding <unk>. This combination.

Rajesh K. Malik: G1 has a robust investigator-initiated study program. We've indicated a variety of areas that are of scientific importance to G1 in the Medical Professionals section of our corporate website, and we welcome the incoming interest today. For those new to this topic, an ISS is a study that is developed and conducted by an independent investigator who serves as a sponsor of the study and assumes full responsibility for its conduct with oversight by an IRB.

Q1 has a robust investigator initiated study program.

Indicated a variety of areas.

<unk> scientific importance GG, one and the medical professionals section of our corporate website and we welcome the incoming interest today.

For those new to this topic and ISS is a study that is developed and conducted by an independent investigator who serves as a sponsor of the study and assumes full responsibility floods conduct with oversight by an IRB.

Rajesh K. Malik: The first ISS we have accepted to support is one in first-line non-small-cell lung cancer, a study of tralocyclin in combination with chemo and a checkpoint inhibitor. We are coming up on a remarkable period for our clinical programs as we expect trials to start reading out around this time next year and then throughout the next several years as we conduct important new trials to generate data to help ensure broad future usage of trilocycline in a variety of current and future treatment paradigms. With that, I'll turn the call over to Jen for a review of the financial results for the third quarter of 2021. Jen?

The first ISS, we have acceptance of support is one in first line non small cell lung cancer.

A study in <unk> in combination with chemo and a checkpoint inhibitor.

We're coming up on a remarkable period for our clinical programs as we expect trials to start reading out around this time next year and then throughout the next several years as we conduct important new trials to generate data to help ensure broad future usage of pilot cyclin and a variety of current and future treatment paradigms.

With that I'll turn the call over to Jen for a review of our financial results for the third quarter of 2021 John.

Jen Moses: Thanks, Raj, and good morning, everyone. As Will mentioned, full financial results for the third quarter of 2021 are available in this morning's press release and will be in the 10-Q, which will be filed after market close. Today I will focus on a few key points from our disclosure. Our total revenue for the third quarter of 2021 was $4.9 million, comprised of net product revenue of $3.6 million and license revenue of $1.3 million.

Raj and good morning, everyone as Rob mentioned, our financial results for the third quarter 2021 are available in this press release and will be in the 10-Q, which will be filed after market close.

Today, I will focus on a few key points from our disclosures.

Our total revenues for the third quarter of 2021 nine.

$9 million comprised of net product revenue of $3 6 million and license revenue of $1 3 million for net product revenue consistent with our last set of guidance, we realized gross to net percentage in the high teens and expect to realize a gross to net percentage in the mid to high teens going forward.

Jen Moses: For net product revenue, consistent with our last set of guidance, we realized a growth-to-net percentage in the high teens and expect to realize a growth-to-net percentage in the mid-to-high teens going forward. Our license revenue was primarily related to clinical trial reimbursements from eQRX and CIMSEER, and delivery of clinical drug supply and manufacturing services to CIMSEER, eQRX, and GCS. The cost of goods sold for the three months ended September 30, 2021, was $0.6 million.

Our license revenue was primarily related to clinical trial reimbursements from HRS and peer and delivery of clinical drug supply and manufacturing services.

Sure.

Cost of goods sold for the three months ended September 32021 was <unk> 6 million and as a reminder, the majority of the manufacturing costs related to the <unk> sales were incurred prior to FDA approval and therefore were recorded as R&D expense in prior periods.

Jen Moses: And as a reminder, the majority of the manufacturing costs related to Coacella sales were incurred prior to FDA approval, and therefore, they were recorded as R&D expense in prior periods. These previously expensed costs will continue to impact the presentation of cost of goods sold in future periods until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold. G1's research and development expenses for the third quarter of 2021 were $21.1 million, compared to $17.9 million for the third quarter of 2020.

Previously expense costs will continue to impact the presentation of cost of goods sold in future periods until initial prelaunch inventory is depleted and additional inventory manufactured and sold.

Q1 research and development expenses for the third quarter of 2021, or $21 1 million compared to $17 9 million for the third quarter of 2020.

Jen Moses: The increase in R&D expenses was primarily due to an increase in clinical trial spend, which is offset by a decrease in expense recognized for the manufacturing of active pharmaceutical ingredients and drug products to support clinical trials. Selling general and administrative expenses for the third quarter of 2021 were $24.3 million compared to $18.4 million for the third quarter of 2020. The increase in SG&A expense was largely due to an increase in commercialization activities, an increase in personnel costs due to increased headcount, an increase in medical affairs costs, information technology spend, professional services, and other administrative costs.

The increase in R&D expenses was primarily due to an increase in clinical trials.

Which is offset by a decrease in expense recognized in the manufacturing of the active pharmaceutical ingredient and drug product to support clinical trial.

Our selling general and administrative expenses for the third quarter of 2021 with $24 3 million compared to $18 4 million for the third quarter of 2020.

The increase in SG&A expense was largely due to an increase in commercialization activities and increase in personnel costs due to increased head count and increased medical affairs costs information technology and professional.

Professional services and other administrative costs.

Jen Moses: Regarding our cash position and runway, as described in the press release this morning, we entered the third quarter with cash and cash equivalents of $212 million, and we recently amended the loan terms and outsized our debt facility with Hercules Capital, which now provides total commitments of $150 million, of which $100 million was fully available as of the amendment closing. The company has drawn down $75 million from this facility in total. This includes the $30 million that had been drawn as of September 30, 2021, and an additional $45 million, which was drawn on November 1, at the close of the amendment.

Regarding our cash position and runway as described in the press release. This morning, we ended the third quarter with cash and cash equivalents and $212 million.

We amended the loan term and advance our debt facility with Hercules capital, which now provides a total commitment of $150 million of which $100 million was fully available as amendment closing.

The company has drawn down $75 million from this facility in total. This includes the $30 million that had been drawn as of September 32021, and an additional $45 million, which was drawn in November at the close of the amendment.

Jen Moses: Including both our cash position as of September 30th and the impact of our amendment agreement with Hercules, we have extended our cash runway and now expect our current financial position to be sufficient to fund operations into 2023. With that, I'll turn the call back over to Jack for some closing comments.

Including both our cash position as of September 30th and the impact of our Amendment agreement with Hercules, we have extended our cash runway and now expect our current financial position to be sufficient to fund operations into 2024 with that I'll turn the call back over to Jack for some closing comments, Jeff Pritchett.

John E. Bailey: Thank you, Jen, Raj, Andrew, and Will. Before we close the call, I want, as always, to thank those people living with cancer for their inspiration. November is Lung Cancer Awareness Month, and I'd like to specifically acknowledge those living with lung cancer and those who have lost to it. We take our obligation to you seriously and are moving quickly with Procella to dramatically improve your chemotherapy experience. And at the same time, we are a nimble company and must move decisively to make changes, additions, and improvements to build short and long-term value. Before we move to Q&A, let me just recap what you've heard today. We have a variety of important commercial tailwinds with none of the traditional barriers that prevent new product launches.

Thank you Jen Raj Andrew well.

Before we close the call I want as always to thank those people living with cancer for their inspiration November.

November is lung cancer awareness month, and I'd like to specifically acknowledge those living with lung cancer and those we have lost too.

We take our obligation to you seriously and are moving quickly with casella to dramatically improve your chemotherapy experience.

And at the same time, we are a nimble company and must move decisively to make changes additions and improvements to build short and long term value.

Before we move to Q&A, let me just recap what you've heard today.

We have a variety of important commercial tailwind with none of the traditional barriers that played new product launches, we have a permanent J code as of October one and no issues with reimbursement.

John E. Bailey: We have a permanent JCO as of October 1 and no issues with reimbursement. Awareness and intention to use remain high. That said, we need to improve execution to move positions from awareness and intention to use to actual use.

Awareness and intention to use remained high.

Said, we need to improve execution to move physicians from awareness and intention to use to actual usage.

John E. Bailey: The experience with the drug, as measured by physician and patient commentary, in addition to account reordering, has been excellent to date. We are making quick progress on hiring our new sales team to provide access to the largest account. We have two new Trial-to-Cycle Phase II trials starting this quarter, one in combination with an ADC, and one to further elucidate its mechanism of action. Both are part of our overall program to maximize the future value and applicability of Trial-to-Cycle.

Experience with the drug as measured by physician and patient commentary. In addition to account reordering has been excellent to date, we are making quick progress on hiring our new sales team to provide access to the largest accounts.

John E. Bailey: While the landscape in second and third line non-small cell lung cancer has changed, causing us to make the strategic decision to revisit our second and third line studies, we expect to support an ISS in first line non-small cell lung cancer. And as a result of our strong cash position at the end of the third quarter and the restructuring of our Hercules Zone, our cash runway now takes us into 2024.

John E. Bailey: Thank you for your time this afternoon. We will speak again in this format in February on the full 2021 call. So I'm sure I'll see many of you during the late fall and winter roadshows and conferences and, hopefully, soon in person.

John E. Bailey: With that, I'll close the call and turn it over to Q&A. Operator, would you please remind our listeners how to ask a question? As a reminder, to ask a question, you will need to start your telephone. To withdraw your question, press the pound key. Please stand by while we compile the QR code. Your first question is from the line of Kaveri Pohlman from BCCI. Your time is over.

Question do you believe.

Starting your liberal but with Roger.

Western press the buggy please spend by welcome.

Sir.

Sure for you to come from the village.

So variable from.

The iced tea.

Miss open.

John E. Bailey: Yeah, good morning. Thanks for taking my question and thanks for the update. Are there any biomarkers you plan to study in relatively cold tumors like colorectal cancer? And my second question is also regarding the CRT study. You're testing Cocella as both a supportive and an anti-tumor drug. Can you tell us your strategy there, how you plan to move forward from the primary endpoints of myeloprotection to secondary endpoints of efficacy? Yeah, thanks, Barbara. I appreciate the question. You're correct, on the CRC we are. I'm gonna take the second one and then flip the first one over to Raj.

Yes. Good morning, Thanks for taking my question and thanks for the update for.

For the mechanism of action are they are new Biomarkers you plan to study in relatively more called tumors like colorectal cancer.

And my second question is also regarding the <unk>. The CRD study you're testing castella as both supportive and antitumor drug can you tell us your strategy. There how you plan to move forward from the primary endpoint of Milo protection to secondary endpoints of efficacy.

Yeah.

The question.

You are correct.

Darcy, we all I'm going to take the second one and then put the first one over to Raj on CRC, we are measuring our emerges in deep mild depression, but we have allocated 20% of the also too.

John E. Bailey: On CRC we are measuring, our primary is indeed myelosuppression, but we have allocated 20% of the alpha to anti-tumor efficacy, so both of those will be studied in that trial. In terms of the first point, in terms of biomarkers in the MOA study, I'll flip that over to Raj. Thanks, Jack. Hi, Kaveri.

Amateur advocacy so both of those will be a study in that in that trial.

In terms of the first point in terms of Biomarkers in the Moh, Sally I'll flip it over to rush. Thanks, Shaq pack of a show the Moh study that I just described as looking specifically for changes within the tumor microenvironment.

Rajesh K. Malik: So the MOA study that I just described is looking specifically for changes within the tumor microenvironment, things that we've discussed before, like Tregs and CD8 levels. I think your question was, are we also looking at biomarkers across our other programs? And the answer is yes.

Things like we've discussed before like T Rex and cd8 levels.

The I think the question was are we also looking at Biomarkers across our other programs and the answer is yes. These will be in the peripheral blood and we'll be looking at very similar.

Rajesh K. Malik: These will be in the peripheral blood, and we'll be looking at very similar markers of immune activation. And I think having the tumor data in the TMBC will really, and the peripheral blood data in the TMBC, will allow us to then make correlations of what we see in the peripheral blood. Got it, thank you.

Microsoft immune activation and I think having the tumor data ended CNBC will really and peripheral blood data and the <unk> will allow us to them make.

<unk> correlations of what we see in the peripheral blood versus the jeweler.

Got it. Thank you then maybe Oh one question.

Rajesh K. Malik: And maybe one question... [inaudible] to determine the mild protection benefit in other tumor types in late-line patients because these are really [inaudible] Thank you. Yeah, so in all of our studies, we're evaluating myeloprotection as well. So, for example, the TMBC study, the BLADR study, the ADC study, so we will have a broad set of myeloprotection data, even beyond the colorectal study, which is where we're focusing on myeloprotection. One of the important outcomes, in addition to anti-tumor efficacy, as Jack mentioned... So as these studies read out, we will have a sense of whether this model protects against a variety of tumors and a variety of chemotherapeutic agents. Operator? Gail?

Let me be a level of off the remedial questions.

Can you run like a solid 34.

My own protection.

To determine.

Protect your benefit and other humor type in referring patients because these aren't really sick patients.

They have beaten up in your system and.

You know like having.

Besides Montana.

Lung cancer would be really helpful. Further education.

Does your posture.

Yeah. So in all of our studies, we're evaluating Mala protection as well. So for example, the TWC study the bladder study the ADC study.

So we will have a broad set of model protection data.

Even beyond the colorectal study, which is where we're focusing on modest protection.

Operator: Well, we seem to be having some logistical issues on the part of our provider. So, it would appear that the best choice right now is to close the call; we'll follow up with everybody after the call. I apologize for the... Technical issues on their end. Okay, well, thank you all. Sorry for the technical difficulties. Just to conclude, we are actively bringing Cocella to people living with extensive stage small cell lung cancer and, as you've heard, conducting intelligently designed clinical trials to maximize the future value and applicability of this drug in a variety of cancers. As always, we look forward to keeping you updated as we move forward, and we will continue to be as transparent and proactive as possible in this regard. Thank you for joining us today. Please stay well.

One of the important outcomes. In addition to antitumor efficacy. This Jack mentioned so as these studies read out we will have a sense of mono protection across a variety protection across a variety of tumors in a variety of chemotherapy medications.

Makes sense. Thank you.

Operator.

Gail.

Well, we seem to be having some.

Just tickle issues on the part of our provider.

So.

It would appear that the best choice right now is to close the call will follow up with everybody. After the call I apologize for the.

Technical issues on their end.

Okay, well. Thank you all sorry for the technical difficulties just to conclude we are actively bringing to sell it to people living with expensive stage small cell lung cancer and is referred to Dr. Peter <unk> designed clinical trials to maximize the future value and applicable witty of this drug and a variety of cancers that is all.

Always we look forward to keeping you updated as we move forward and we will continue to be as transparent and proactive as possible. In this regard. Thank you for joining us today, we stay well.